Non Clinical Research Coordinator
|Department:||Research Program |
|Schedule:||Full time |
|Shift:||Day Shift |
|Hours:||8:30AM - 5:00PM |
Perform a wide variety of start-up activities integral to the successful application and acceptance of essential regulatory documents. Assist in insuring timely submission of complete, accurate and neat documents to pharmaceutical sponsors, IRB, and contract research organizations, where applicable.
Manage research account receivables and research financial cycle. Assist in clinical studies budget. Prepare and maintain research contract files.
Offer administrative support to the Office of Research.
Minimum Education and/or Experience:
Bachelor's degree in a health-related or science field
Two years’ experience in a clinical research-related field
Clinical Research Coordinator certification preferred
POSITION EXPECTATIONS & RESPONSIBILITIES:
1. Application Skills – The effectiveness with which the employee applies job knowledge and skill to job assignments (job knowledge, analyzes problems, employs tools of the job, follows procedures, tracking, systems upkeep)
· Expected to be able to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations.
· Expected to have basic mathematical skills.
· Expected to be familiar with Microsoft Windows.
· Expected to be efficient in Internet resource utilization.
· Expected to possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility.
2. Quality of Work – The manner in which the employee completes job assignments (accuracy or precision, thoroughness/neatness, reliability, follow-through/follow-up, judgment/decision making)
· Expected to prepare a summary of tasks reports.
· Expected to prepare regulatory status reports.
· Expected to manage the update of study regulatory documents. These documents include but are not necessarily limited to Revised 1572, Protocol Amendments, safety reports, site delegation signature logs and other documents.
· Expected to regularly, and as needed, meet with the Research Director to discuss new studies and the updating of current studies.
· Expected to assist with site visits and meet with study monitors.
· Expected to on a monthly basis, update IRB summaries for current studies.
· Expected to on a timely basis, add all new studies to the cumulative reports.
· Expected to complete, accurately and in a timely fashion, all documents needed in preparation for submission to the IRB. These documents include, but are not necessarily limited to, submission letters, questionnaires, generic advertisements, and other miscellaneous documents.
· Expected to ensure IRB approval is granted before turning any documents over to Clinical Research Coordinators.
· Expected to submit safety reports in a timely fashion.
· Expected to manage the update, on an annual basis or otherwise “as needed,” and maintain all curriculum vitae for physicians and research staff as well as all the credentials needed to conduct research in the organization such as Human Research Subject Protection Training and Good Clinical Practice.
· Expected to regularly manage the update of all nursing and medical licenses on file for physicians, physicians’ assistants, research coordinators, and other staff, and all outside physicians, physicians’ assistants, and nurse practitioners.
· Expected to learn, apply and utilize computer software applications to enhance work flow and study activity efficiency.
· Expected to negotiate Clinical Trial Contracts and Budgets
· Expected to maintain and negotiate new service agreements with outside vendors.
· Expected to provide information to Research Director for month end research financial reporting.
· Expected to manage Research Accounts Receivables such as invoicing; collecting payments; screen fail tracking.
· Expected to coordinate research billing with business office.
· Expected to support research staff by education and training in research related charges and research billing.
· Expected to create and maintain good relationships with pharmaceutical sponsors and vendors.
*Incumbent may be required to perform emergency duty before, during and/or beyond normal work hours or days in the event of an emergency, crisis situation or disaster (man-made or natural) including evacuation sites.
*The person in this position will work in a smoke-free location, and is expected to adhere to all smoking restrictions.
*In the spirit of wellness for both our employees and patients, Boca Raton Regional Hospital has instituted a mandatory influenza prevention vaccination program. Current employees must receive the influenza prevention vaccination free of charge during the recognized flu season. As a condition of employment, new hires will be required to comply with all program rules. This is a mandatory program with the exception of documented medical or religious reasons for not receiving the vaccine. For further information on this progressive program, please contact Boca Raton Regional Hospital’s Human Resources Department at 561-955-4075.